{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"55.5"},{"groupId":"OG001","value":"70.2"},{"groupId":"OG002","value":"68.7"}]}],"title":"CCyR at M12"},{"categories":[{"measurements":[{"groupId":"OG000","value":"61.5"},{"groupId":"OG001","value":"66.0"},{"groupId":"OG002","value":"66.2"}]}],"title":"CCyR at M24"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14.1"},{"groupId":"OG001","value":"9.2"},{"groupId":"OG002","value":"12.8"}]}],"title":"CCyR at M36"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11.3"},{"groupId":"OG001","value":"8.9"},{"groupId":"OG002","value":"13.5"}]}],"title":"CCyR at M48"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"2.8"},{"groupId":"OG002","value":"2.8"}]}],"title":"CCyR at M60"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1.8"},{"groupId":"OG001","value":"1.8"},{"groupId":"OG002","value":"2.8"}]}],"title":"CCyR at M72"}],"denoms":[{"counts":[{"groupId":"OG000","value":"283"},{"groupId":"OG001","value":"282"},{"groupId":"OG002","value":"281"}],"units":"Participants"}],"description":"CCyR is defined as 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics. Patients with no CCyR as the best response by any specific time point, all missing cytogenetic evaluations by that time point or Ph- at baseline are combined as \"Nocomplete cytogenetic response\".","groups":[{"description":"Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated","id":"OG000","title":"Imatinib 400 mg QD"},{"description":"Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.","id":"OG001","title":"Nilotinb 300 mg BID"},{"description":"Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.","id":"OG002","title":"Nilotinib 400 mg BID"}],"paramType":"NUMBER","populationDescription":"Full analysis Set (FAS): Contained 846 randomized patients. Patients were analyzed according to the treatment they were randomized to, regardless of actual treatment received.","reportingStatus":"POSTED","timeFrame":"12, 24, 36, 48, 60, 72 months (M)","title":"Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months and Beyond 12 Months","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}